Purpose

This document sets out the key features regarding processing and responding to requests for datasets from the DSINE-Africa project. This process is useful to comply with ethical obligations, understand what data is requested, and understand the purpose of the request. This internal procedure applies to staff of DSINE-Africa who request a subset of data to prepare a report, manuscript, seminars, thesis, conference paper, or any other relevant scientific activity. When it comes to database access, there are several considerations and steps must be fulfilled to ensure efficient, security and patient safety.

Data Requestor

A data requestor (DR) is a qualified person affiliated with or conducting research under the mentorship or supervision of DSINE-Africa staff. This includes Directors, PIs, Research and post-doctoral fellows, students, etc.

User Request

A user initiates a dataset access by submitting a request to the data manager, specifying the data needed from the database. This must be made by filling out a data request form (DRF to be made available at the DSINE-Africa website). A complete data request form must be filled and submitted with relevant attachment (form available here). Verbal or any other form of request for a dataset will not be processed. All requests must be processed when they are received, and datasets will be made available only upon approval.

Requirements for data request

To be able to respond to the data requests in a timely manner, the user should submit his or her request using a data request form (see draft template in Annex 1). Information indicated in the required field must be provided.

Parameters that can assist in narrowing the scope of review include making reference to specific sites, the time period or frame in which the information was generated and being specific about the nature of the data sought (e.g., indexing a particular form, a list of variables, indicating a timeframe).

Data subject protection: D-SINE Africa databases are stored to align with HIPAA requirements to safeguard Protected Health information of the project’s participants. Hence, anyone requesting access and use of derived datasets must have completed and passed at least UCLA Ethics Training – Human Subjects Research (HSR) Modules Biomedical Research Basic Course and the certificate must be provided upon request.

The requestor undertakes to use the data only for the purposes stated in the ‘Data Access Request Form,’ after which the final dataset (modified dataset) and codes used for processing analysis will be submitted to DSINE-Africa for archiving. If DR wishes to use the data for other research not stated in the initial request, he will submit a new application for approval. Datasets requested should not be used beyond the framework of the DSINE-Africa Project, as indicated in the consent form signed by the subject. Users must comply with the data sharing and use policy of DSINE-Africa and the permissions stipulated in the subject’s consent forms. Use of the data and/or results obtained from use of the data for any purpose other than research or teaching is prohibited. The requestor will not attempt to identify, or claim to identify, any record in a manner that would breach privacy or data protection laws. Further, he should not attempt to match or claim to have matched data relating to individuals or participating bodies to any other data. 

Processing a dataset request

Upon receipt, the data manager will acknowledge the request. The DM will verify the user’s credentials. The requestor may be asked to complete or update a data request form to better enable the team to locate the relevant information. The data manager must check and confirm the identity of anyone making a DR to ensure information is only given to the person who is entitled to it. Requestors are encouraged to use their institutional email if possible and indicate that their mentor is working with D-SINE Africa to facilitate this process. 

Upon receipt of the data request form, the DM will review the document. If reasonably satisfied with the information, the DM will notify the requestor that his or her request will be responded to within an indicated timeframe (24–72 hours). The DM will verify the identity of the DR, then seek the opinion of the project reviewers, and if approved, the request will be processed. Hence, the requested dataset (to be generated through codes prepared by data analysts) will be made available through a specific box folder and the link shared with the requestor (any other way to grant access to the requested subset of data??), with DAs, reviewers, and project leads in copy. Based on the information supplied in the DRF, the data manager will also notify the DR of the provisional date for submitting the analytical output for archiving.

The DM will provide the finalized response together with the information retrieved from the reviewers (project lead and/or a statement that DSINE does not hold the information requested) and ensure that a written response will be sent back to the DR via email.

After the requestor has submitted his analytical output (modified dataset and codes for processing analysis) to the DAs, the data request will be considered closed, documented, and archived. The request form will be archived in the same Box folder as the shared dataset.

Withdrawal of authorization

Permission to use a subset of data for the specified purpose may be withdrawn by D-SINE Africa at any time by written notice to the requestor signed by the director if a violation of the terms and conditions of this data request and access procedure is observed.

Responsibilities

Data requestor

The DR must ensure he complies with the data dissemination and sharing policy of D-SINE Africa. He is responsible of:

• Submitting the DRF containing the required information into the DM.
• Responding to any clarification we may request to better understand the purpose of the request.
• Ensuring data is used without breaching an ethical issue.
• Should not share requested dataset with a third party without approval/authorization from the D-SINE Africa.
• Keeping records for all codes with an amended data dictionary used in the DAs or in a GitHub account for archiving.
• Providing the modified dataset used for the final analysis.
• Disseminate Research Findings by sharing Share project’s outcomes through appropriate channels, i.e publishing research findings in journals or presenting them at conferences.
• Must acknowledge US National institute of Health (NIH) who granted funding to generate data.

Data manager

• Ensuring compliance with the terms and conditions of this data request and access procedure
• Controls for record protection
• Received request and pre-assess before transmission to the reviewers.
• Return the request to the requestor for completion if important information is provided.
• Communicate the outcome of the review process to the requestor.
• Communicate with the DAs for data sub-setting and cleaning.
• Ensure only authorized persons have access to the dataset.
• Ensure quality control as an integral part of all dissemination steps.
• Ensure Preservation and Archiving of shared data and documentation files.
• Ensure effective disclosure analysis to protect respondent confidentiality.
• Archiving keys for deidentified datasets in a secured Box folder.

Reviewers

Who will review the requests? Directors? PIs, PMs

The responsibilities of the reviewers include

• Verify and validate the identity of the data requestor.
• Appraise the purpose of the request and identify potential unanticipated issue, including violations of the subject
• Appraise the scope of the requested data (time frame, list of variables, target group, etc. ) in relation to the purpose of the projected study.
• Approve or disapprove the request, by replying to the DM for action.

Data analysts

• De-identification of datasets,
• Produce friendly data files that are easy for DR to use.
• Preparation of code for de-identification, variable selection, and subsetting of a clean dataset to be made available to the requestor;
• Monitoring disseminated data and documenting the ouput of analysis.

Document version history

Annex 1: D-SINE Africa Data Request Form (DRF)